A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE).
Journal
ERJ open research
ISSN: 2312-0541
Titre abrégé: ERJ Open Res
Pays: England
ID NLM: 101671641
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
received:
18
12
2020
accepted:
07
01
2021
entrez:
5
4
2021
pubmed:
6
4
2021
medline:
6
4
2021
Statut:
epublish
Résumé
Chronic breathlessness, persistent and disabling despite optimal treatment of underlying causes, is a prevalent and frightening symptom and is associated with many emergency presentations and admission to hospital. Breathlessness management techniques used by paramedics may reduce the need for conveyance to hospital. The Breathlessness RElief AT HomE study (BREATHE) aims to explore the feasibility of conducting a definitive cluster randomised controlled trial (cRCT) for people with acute-on-chronic breathlessness who have called an ambulance, to evaluate the effectiveness and cost-effectiveness of a paramedic-administered non-pharmacological breathlessness intervention. The trial is a mixed-methods feasibility cRCT. Eight paramedics will be randomised 1:1 to deliver either the BREATHE intervention in addition to usual care or usual care alone at call-outs for acute-on-chronic breathlessness. Sixty participants will be recruited to provide access to routine data relating to the index call-out with optional follow-up questionnaires at 14 days, 1 month and 6 months. An in-depth interview will be conducted with a subgroup. Feasibility outcomes relating to recruitment, data quality (especially candidate primary outcomes), and intervention acceptability and fidelity will be collected as well as providing data to estimate a sample size for a definitive trial. Yorkshire and The Humber-Sheffield Research Ethics Committee approved the trial protocol (19/YH/0314). The study results will inform progression to, or not, and design of a main trial according to predetermined stop-go criteria. Findings will be disseminated to relevant stakeholders and submitted for publication in a peer-reviewed journal.
Identifiants
pubmed: 33816602
doi: 10.1183/23120541.00955-2020
pii: 00955-2020
pmc: PMC8005684
pii:
doi:
Types de publication
Journal Article
Langues
eng
Informations de copyright
Copyright ©The authors 2021.
Déclaration de conflit d'intérêts
Conflict of interest: M. Northgraves has nothing to disclose. Conflict of interest: J. Cohen reports grants from the NIHR during the conduct of the study. Conflict of interest: V. Allgar has nothing to disclose. Conflict of interest: D. Currow reports he is an unpaid advisory board member for Helsinn Pharmaceuticals. He is a paid consultant and receives payment for intellectual property with Mayne Pharma and is a consultant with Specialised Therapeutics Australia Pty. Ltd. Conflict of interest: S. Hart reports personal fees and nonfinancial support from Chiesi UK; and grants, personal fees and nonfinancial support from Boehringer Ingelheim, all outside the submitted work. Conflict of interest: K. Hird has nothing to disclose. Conflict of interest: A. Hodge has nothing to disclose. Conflict of interest: M. Johnson has nothing to disclose. Conflict of interest: S. Mason has nothing to disclose. Conflict of interest: F. Swan has nothing to disclose. Conflict of interest: A. Hutchinson has nothing to disclose.
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